Comparing BCMA CAR-T therapy to stem cell transplant for multiple myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study is a prospective, non-inferiority trial that evaluates the effectiveness of BCMA CAR-T cell therapy compared to autologous hematopoietic stem cell transplantation (ASCT) in patients with newly diagnosed multiple myeloma. Participants will receive either treatment following a regimen of VRD±D. The goal is to determine if BCMA CAR-T therapy is as effective as ASCT for transplant-eligible patients. The study will involve measuring disease response and patient outcomes over time.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Be informed and voluntarily sign the Informed Consent Form (ICF).
2. Age between 18 and 70 years (inclusive).
3. Have measurable disease meeting at least one of the following criteria: Serum M-protein ≥1 g/dL (\>10 g/L) as detected by serum protein electrophoresis (SPEP), or quantifiable IgA or IgD levels for IgA or IgD-type myeloma; Urine M-protein ≥200 mg/24 hours; In cases where serum and urine M-protein do not meet the above thresholds, an abnormal free light chain (FLC) ratio (normal range: 0.26 to 1.65) and involved serum FLC ≥100 mg/L.
4. Confirmed expression of the BCMA target antigen on MM cells by flow cytometry or bone marrow immunohistochemistry.
5. Assessed by the investigator as transplant-eligible.

Exclusion Criteria:

1. Primary plasma cell leukemia.
2. Concurrent amyloidosis.
3. Involvement of the central nervous system (CNS).
4. Previous treatment with BCMA-targeted therapy or CAR-T cell therapy.

Where it's running

• Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
  Tianjin, China Recruiting

Study contacts

• Study coordinator: Gang An, PhD&MD
• Email: angang@ihcams.ac.cn
• Phone: 86-022-23909171

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• BCMA-TGFβ CAR-T Cells in Relapsed or Refractory Myeloma

  A one-arm phase 1 study tests a new BCMA-TGFβ CAR-T cell therapy to see if it is safe and provides signs of benefit in adults whose multiple myeloma has come back or persisted after prior treatments.

  Recruiting Phase 1 Medical College of Wisconsin · Milwaukee, Wisconsin · NCT05976555

• CAR-T therapy outcomes and quality of life in older adults with B‑cell lymphoma

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• In Vivo CD19/CD20 CAR T-Cell Therapy for Relapsed or Refractory B-Cell Lymphoma

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  Recruiting Phase 1 Chinese PLA General Hospital · Beijing · NCT07775508

• Understanding CAR-T Toxicities After Cilta-Cel in Multiple Myeloma

  This observational study tests how patients with multiple myeloma respond to cilta-cel treatment by tracking toxicities and trying to spot biomarkers to guide care.

  Recruiting at 3 sites Icahn School of Medicine at Mount Sinai · San Francisco, California and 2 other locations · NCT07665307

• PD-1Ab21-BCMA CAR-T consolidation for multiple myeloma with renal dysfunction

  This trial will test a BCMA-targeted CAR-T cell therapy that secretes a PD-1 antibody and interleukin-21 fusion protein as consolidation treatment for people with multiple myeloma who have kidney dysfunction.

  Recruiting Phase 2 Chinese PLA General Hospital · Beijing, Beijing Municipality · NCT07489534

• DC/MM fusion vaccine plus BCMA CAR-T for relapsed or refractory multiple myeloma

  This trial will test whether adding a personalized DC/MM fusion vaccine (with GM‑CSF) to standard BCMA CAR‑T therapy helps people with relapsed or refractory multiple myeloma.

  Recruiting Phase 1 Beth Israel Deaconess Medical Center · Boston, Massachusetts · NCT07377435

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.